Reducing Radiation Target Volume for Stage IIb Cervical Cancer

NCT ID: NCT07249957

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-10-31

Brief Summary

This is a domestic single-center prospective clinical trial. The study selected patients with histologically confirmed cervical squamous cell carcinoma, diagnosed as stage IIb according to the FIGO 2018 staging principle (tumor size < 4 cm). The patients first received 6 cycles of induction chemotherapy (carboplatin (AUC2) + paclitaxel (80 mg/m2), q1w), followed by concurrent chemoradiotherapy with a platinum-based regimen. The external beam radiation field only covered the entire uterus (including the primary lesion of the cervix), the bilateral parametrium, and the lesion of the cervix/vagina extending 3 cm downward. A total of 60 participants are planned to be included in the study.

Conditions

Stage IIb Cervical Cancer Radical Radiotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radical radiotherapy for IIb cervical cancer to reduce the irradiation area

Group Type: EXPERIMENTAL

The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.

Intervention Type: RADIATION

The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.

Interventions

The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.

The external irradiation area only covers the entire uterus (including the primary lesion in the cervix), bilateral parametrium, and 3 cm below the cervical/vaginal lesions.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. The patient voluntarily participated in this study and signed the informed consent form;

2. Age range: 50 to 75 years old;

3. Patients with cervical cancer who had not undergone surgery or chemotherapy and were initially diagnosed with squamous cell carcinoma by pathological histology, and were HPV high-risk positive;

4. According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size < 4 cm);

5. ECOG score: 0 to 1, with an expected survival of more than 6 months;

6. Pregnant women must undergo a pregnancy test (serum or urine) 7 days before enrollment, and the result must be negative, and they are willing to use appropriate contraceptive methods during the trial;

7. According to the investigator's judgment, there are no absolute contraindications to radiotherapy and chemotherapy or surgery, and they can comply with the trial protocol.

Exclusion Criteria

1. Active or uncontrolled severe infections;

2. Cirrhosis, decompensated liver disease;

3. History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases;

4. Chronic renal insufficiency and renal failure;

5. Patients with other malignancies that require treatment and/or newly diagnosed within 5 years;

6. Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification);

7. Patients who have undergone pelvic artery embolization;

8. Patients who have received radiotherapy for pelvic malignant tumors in the past;

9. Patients who have received partial hysterectomy or radical hysterectomy in the past;

10. Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs;

11. Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.;

12. Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form;

13. Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dongling Zou

Director of Dept. of Gynecological Oncology Chongqing University Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CQGOG0116

Identifier Type: -

Identifier Source: org_study_id